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Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma Clinical research trials and Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma. Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma  Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
For Condition: primary central nervous system lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma.
Details: OBJECTIVES: - Determine the complete radiographic response in patients with newly diagnosed primary CNS lymphoma treated with methotrexate and thiotepa. - Determine the duration of progression-free survival and overall survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Determine whether tumor expression of BCL-6 is associated with response to this chemotherapy regimen and survival of these patients. - Describe the relationship between initial response to steroids (if administered), response to this chemotherapy regimen, and survival of these patients. OUTLINE: This is a multicenter study. Patients receive thiotepa IV over 15 minutes on day 1. Patients also receive methotrexate IV over 4 hours on days 1 (8 hours after thiotepa) and 14. Beginning 24 hours after the start of methotrexate infusion, patients receive leucovorin calcium IV or orally every 6 hours until rescue is achieved. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving disappearance of enhancement of disease on MRI receive an additional 28-day course followed by maintenance therapy comprising thiotepa and methotrexate once a month for 11 courses. Patients undergo neuro-ophthalmologic exams annually for 2 years. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study within 8-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary CNS lymphoma - Confirmed by 1 of the following: - Brain biopsy or resection - CSF cytology - Positive cytology or immunohistochemical diagnosis of monoclonality and measurable intracranial tumor - Vitreal biopsy - Measurable and contrast-enhancing disease on the postoperative, pretreatment MRI or CT scan - No radiographic evidence of ascites or pleural effusions PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - SGOT no greater than 4 times upper limit of normal Renal - Creatinine no greater than 2 mg/dL - Creatinine clearance at least 50 mL/min Other - Mini mental score of at least 15 - HIV negative - Able to achieve hydration - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ - No allergy to methotrexate - No serious infection - No medical illness that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy or biologic therapy for this disease Chemotherapy - No prior chemotherapy for this disease - No other concurrent chemotherapeutic agents Endocrine therapy - No prior hormonal therapy for this disease - Prior glucocorticoid therapy allowed Radiotherapy - No prior radiotherapy for this disease - No prior cranial irradiation Surgery - See Disease Characteristics Other - At least 1 week since prior salicylates, non-steroidal anti-inflammatory drugs, probenecid, folic acid, or sulfonamide medications - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TracyBatchelor, Study Chair, Massachusetts General Hospital
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting John Laterra 410-955-8964
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting David Lawson 404-778-4189
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting E. Chiocca 617-726-3779
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting David Peereboom 216-445-6068
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3295
United States
Recruiting James Markert 205-975-6985
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Glenn Lesser 336-716-9527
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jane Alavi 215-662-6319
Additional Information:
Study ID Numbers: CDR0000256605; JHOC-NABTT-2109,NABTT-2109
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045539
Other Primary Central Nervous System Lymphoma Studies:
1. Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
2. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
3. Autologous Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
4. Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
5. Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
Related Studies:
Other primary central nervous system lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
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